RIFAFOUR e-275 Film-coated tablet Ref.[115257] Active ingredients: Ethambutol Isoniazid Pyrazinamide Rifampicin

Take RIFAFOUR e-275 tablets with a full glass of water 1 hour before, or 2 hours after a meal. However, if gastrointestinal irritation occurs, the tablets may be taken with food. If aluminium-containing antacids are taken, administer one hour after the tablet dose.

The recommended treatment dosages, based on the patient's body weight, given daily for the 2 month initial-phase treatment in adults and children over 13 years of age are as follows:

30 – 37 kg 2 tablets
38 – 54 kg 3 tablets
55 – 70 kg 4 tablets
71 kg and over 5 tablets

There is limited overdose information involving rifampicin, isoniazid, pyrazinamide and ethambutol in combination.

Symptoms

Rifampicin

Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur.

Brownish-red or orange discolouration of the skin, urine, sweat, saliva, tears and faeces will occur and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular dysrhythmias, seizures and cardiac arrest were reported in some fatal cases.

Nonfatal acute overdoses in adults have been reported with doses ranging from 9 g to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14 g to 60 g. Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one or two doses have been reported.

Isoniazid

Isoniazid overdosage produces signs and symptoms within 30 minutes to 3 hours after ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring of vision and visual hallucinations are among the early manifestations. With marked overdosage, respiratory distress and CNS depression, progressing rapidly from stupor to profound coma are to be expected, along with severe, intractable seizures. Severe metabolic acidosis, acetonuria and hyperglycaemia are typical laboratory findings.

Pyrazinamide

There is limited information related to pyrazinamide overdosage. Liver toxicity and hyperuricaemia may occur with overdosage.

Ethambutol

There is limited information related to ethambutol overdose. Loss of appetite, gastro-intestinal disturbances, fever, headache, dizziness, confusion and hallucinations may occur.

Management

In case of overdosage with RIFAFOUR e-275, gastric lavage should be performed as soon as possible. Following evacuation of the gastric contents, the installation of activated charcoal slurry into the stomach may help absorb any remaining medicine from the gastrointestinal tract. Anti-emetic medication may be required to control severe nausea and vomiting.

Intensive support measures should be instituted, including airway patency and individual symptoms treated as they arise.

Store in a cool place, at or below 25°C in well-closed containers, protected from light.

KEEP OUT OF REACH OF CHILDREN.

Packs of 20, 28, 40, 56, 60, 80, 84, 100, 112 and 500 tablets in foil-foil blisters or white polypropylene securitainers.